Clinical Research

• Provide general data management support to project teams, sponsors, and external vendors
• Develop eCRF specifications, including data capture screens and edit check specifications
• Program, maintain, validate, and test clinical databases and EDC systems
• Develop eCRF completion guidelines and training materials
• Train site users and monitors on clinical databases
• Develop data transfer agreements and specifications with external-data vendors
• Reconcile external data with EDC data and sponsor safety databases when needed
• Support development of external clinical data systems such as ePRO and IWRS and document/test data transfers
• Develop data management plans and related documentation
• Perform ongoing data review and cleaning through database lock/close
• Code medical terms in clinical databases as required
• Generate data listings and reports for data review and database close/lock
• Monitor study status and provide data status reports
• Maintain complete and current data management documentation in the TMF
• Activate/deactivate database users and maintain request records
• Respond to users needing EDC system assistance
• Archive clinical databases and related documents
• Participate in writing and updating data management SOPs
• Mentor and train a Clinical Data Coordinator
• Oversee outsourced vendors to ensure timelines, deliverables, sponsor requirements, protocol requirements, work orders, and SOPs are met

Clinical Research jobs in Philippines

Clinical Data Manager